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Completed

NCT Number: NCT04182919

"Efficacy and Safety of Phlai Capsule Compared to Placebo as the Treatment in Allergic Rhinitis Patients"

Background: Zingiber cassumunar Roxb., frequently known as Phlai in Thai, has been safely used as an antihistaminic and anti-inflammatory drug in Thai traditional medicine. Individual with allergic rhinitis may have positive response to Phlai.

Objective: Investigators assessed the efficacy and safety of Phlai as a treatment for allergic rhinitis Design: The study was a 1-month, double-blind, randomized, parallel-group, intent-to-treat, multicenter, controlled trial in 267 patients at 7 hospitals in Thailand. Skin prick test-positive adults with allergic rhinitis ages 18 to 50 who were randomized into 3 groups (Phlai 8mg/d, Phlai 4mg/d, placebo).

Main outcome measures: Primary outcome was defined: improvement of total 5 symptoms scores (nasal obstruction, rhinorrhea, sneezing, itchy nose, itchy eyes) over a 4-week interval among Phlai 8mg/d, Phlai 4mg/d and placebo. Secondary endpoints were: assessments of rhinoconjunctivitis quality of life questionnaire, peak inspiratory nasal flow, nasal examination, adverse events, AST, ALT, Creatinine and BUN over a period of 4 weeks.

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Key information

Conditions

Allergic Rhinitis Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Minh Phuoc Hoang, MD

Bangkok, 10330, Thailand

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18-50 years old
  • Allergic rhinitis following diagnostic criteria of ARIA guideline
  • Reflective total 5 symptoms score 2-10 per day for 3 consecutive days (total score=15) and not greater than 10 in any days during the past week
  • Positive skin prick test to at least one aeroallergen: wheal size ≥ 3 mm greater than negative control
  • Not receiving intranasal corticosteroid + intra antihistamine for 2 weeks , intranasal corticosteroid for 2 weeks, systemic corticosteroid for 4 weeks, antihistamine for 1 week, nasal decongestant for 1 week and leukotriene receptor antagonists for 1 week

Exclusion criteria

  • Serious medical underlying diseases e.g. COPD, Heart disease, Chronic renal failure, chronic hepatic failure
  • Allergic rhinitis and asthma which require immunotherapy
  • Receiving antidepressants, sedative, anxiolytic, opioids, neuroleptic
  • Uncontrolled asthma which requires steroid inhaler, LABA and does not use leukotriene receptor antagonists
  • Previous nasal surgery for nasal polyp, nasal septum deviation
  • Acute or chronic rhinosinusitis
  • Pregnancy and lactation (Urine pregnancy test is allowed and paid by researchers)
  • Allergic to any kinds of herb
  • Refusal to participation

Treatment and study plan

Phlai

Drug

Each capsule contains 4 mg compound D. Using orally in the evening everyday in 4 weeks

Other names: Zingiber cassumunar

Placebo oral capsule

Drug

Like Phlai capsule extract : :PVP K30, Calcium carbonate, Dibasic calcium phosphate, Sodium starch glycolate, Colloidal silicon dioxide, Ethanol 96%, Purified water, Magnesium stearate. Not having compound D. Using orally in the evening everyday in 4 weeks

Primary outcomes

  1. Total five symptoms score (T5SS)

    Time frame: 24 hours

    T5SS: (nasal obstruction, rhinorrhea, sneezing, itchy nose, itchy eyes). For each symptom:

    0: no symptoms

    • mild
    • moderate
    • severe. Participants assess T5SS everyday. Self assessment twice a day Bedtime : reflective symptoms score Morning :instantaneous symptoms score. The mean score of two assessment is the T5SS. Investigator will calculate the mean T5SS in the follow up

Secondary outcomes

  1. Rhinoconjunctivitis Quality of Life Questionaire (RCQ-36) Thai version

    Time frame: 4 weeks

    This questionnaire is designed to find out how your health and well-being have been affected by rhinoconjunctivitis.

  2. Peak inspiratory nasal flow (PNIF)

    Time frame: 2 weeks

    Use to measure nasal airflow during maximal inspiration

  3. Nasal examination

    Time frame: 2 weeks

    Outcome assessor in each site will check the three symptoms: nasal swelling, pale and nasal discharge by anterior rhinoscopy

  4. Adverse events

    Time frame: 2 weeks

    Sedation, dizziness, dry mouth, headache

  5. AST Level

    Time frame: 4 weeks

    Liver function test

  6. ALT Level

    Time frame: 4 weeks

    Liver function test

  7. Creatinine level

    Time frame: 4 weeks

    Renal function test

  8. BUN

    Time frame: 4 weeks

    Renal function test

  9. Eosinophils blood level

    Time frame: 4 weeks

    CBC test

  10. Lymphocyte blood level

    Time frame: 4 weeks

    CBC test

  11. Hemoglobin

    Time frame: 4 weeks

    CBC test

  12. Platelet level

    Time frame: 4 weeks

    CBC test

Sponsors and collaborators

Lead sponsor

Chulalongkorn University

Other

Collaborators

  • Government Pharmaceutical Organization

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 2, 2019
Registry last updated
Jan 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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